MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-29 for ADVIA CENTAUR XP INSULIN (IRI) ASSAY N/A 02230141 manufactured by Kyowa Medex Co., Ltd. (japan) For:.
[54276213]
The reagents were checked by the customer. There were no visible clumps. The quality control (qc) and the calibrations were acceptable. The field service engineer (fse) verified the hardware performance and found all data satisfactory. The field application specialist (fas) also performed other precision checks and sample correlations for the insulin (iri) assay. All the data was satisfactory. The cause for the discordant advia centaur xp insulin (iri) result is unknown. Pre- analytical factors may be the possible cause of the discordant result. The instrument is performing within specification. No further evaluation of the device is required. The ifu states on the interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. "
Patient Sequence No: 1, Text Type: N, H10
[54276214]
A falsely elevated advia centaur xp insulin (iri) result was obtained on a patient sample. The patient sample was repeated and the result was elevated. The physician sent the patient sample to another laboratory ((b)(6) lab) to be tested on an alternate platform. The result was lower. The same sample was tested at another location ((b)(6)) on the advia centaur xp and the result was similar to the alternate platform. The sample was then tested at the customer site on the advia centaur xp and the result was similar to the alternate platform. It is unknown if patient treatment was prescribed or altered. There was no report of adverse health consequences due to the insulin (iri) discordant results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2016-00153 |
| MDR Report Key | 5910301 |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-08-08 |
| Date Mfgr Received | 2016-08-09 |
| Date Added to Maude | 2016-08-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EIMAN SULIEMAN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604603 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | E. WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA CENTAUR XP INSULIN (IRI) ASSAY |
| Generic Name | INSULIN IMMUNOASSAY |
| Product Code | CFP |
| Date Received | 2016-08-29 |
| Model Number | N/A |
| Catalog Number | 02230141 |
| Lot Number | 164 |
| Device Expiration Date | 2016-12-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYOWA MEDEX CO., LTD. (JAPAN) FOR: |
| Manufacturer Address | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-29 |